Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults

Sponsor
Nicola Goekbuget (Other)
Overall Status
Completed
CT.gov ID
NCT00199082
Collaborator
(none)
650
1
1
95
6.8

Study Details

Study Description

Brief Summary

The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
650 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7)
Study Start Date :
Jul 1, 2002
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement

Drug: Adriamycin

Drug: Cyclophosphamide

Drug: Cytarabine

Drug: Dexamethasone/Prednisolone

Drug: VP16

Drug: Ifosfamide

Drug: Methotrexate

Drug: G-CSF

Drug: Rituximab

Drug: Vincristine/Vindesine

Procedure: Irradiation (in specific conditions)

Outcome Measures

Primary Outcome Measures

  1. Remission rate []

  2. Remission duration []

  3. Disease free survival []

  4. Overall survival []

Secondary Outcome Measures

  1. Dose and time compliance []

  2. Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) []

  3. Death under therapy and in complete remission (CR) []

  4. Localisations of relapse []

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma

  • Age > 15 years

  • Written informed consent

Exclusion Criteria:
  • Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected

  • HIV infection

  • Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy

  • Known severe allergy to foreign proteins

  • Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy.

  • Pregnancy or nursing

  • Participation in other studies that interfere with study therapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital, Medical Dept. II Frankfurt Germany 60590

Sponsors and Collaborators

  • Nicola Goekbuget

Investigators

  • Principal Investigator: Nicola Goekbuget, Dr. med., University Hospital of Frankfurt (Main)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nicola Goekbuget, Study Coordinator, Goethe University
ClinicalTrials.gov Identifier:
NCT00199082
Other Study ID Numbers:
  • GMALL05
First Posted:
Sep 20, 2005
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022

Study Results

No Results Posted as of Aug 19, 2022